Regulatory Focus™ > News Articles > FDA: Custom Ultrasonics' Endoscope Reprocessors Still Unsafe

FDA: Custom Ultrasonics' Endoscope Reprocessors Still Unsafe

Posted 17 August 2016 | By Michael Mezher 

FDA: Custom Ultrasonics' Endoscope Reprocessors Still Unsafe

The US Food and Drug Administration (FDA) on Wednesday said it is maintaining its recommendation against the use of Custom Ultrasonics' System 83 Plus automated endoscope reprocessors (AERs) to clean duodenoscopes after finding the reprocessors were not adequately validated last November.

However, in a shift from FDA's previous recommendation in February, the agency now says healthcare facilities can resume using the devices to clean other types of flexible endoscopes.

Superbug Outbreaks

Duodenoscopes made headlines in early 2015 after Carbapenem-resistant enterobacteriaceae (CRE) outbreaks at Virginia Mason Medical Center in Seattle, WA and UCLA Ronald Reagan Medical Center in Los Angeles were traced to the devices.

According to FDA, the infections were caused by inadequate cleaning of the devices, which are more difficult to clean than other types of flexible endoscopes.

In January, a year-long Senate investigation into duodenoscopes linked the devices to at least 25 superbug outbreaks that affected some 250 patients in the US and Europe between 2012 and 2015. Ultimately, the report concluded that current postmarket surveillance systems for medical devices are ineffective, and called for greater authority for FDA to deny 510(k) submissions over insufficient validation data.

In addition to discussing failings by the three manufacturers that market duodenoscopes in the US, Olympus, Pentax and Fujifilm, the Senate report singles out Custom Ultrasonics, alleging the company's AERs contributed to nine of the 16 domestic outbreaks.

Custom Ultrasonics Recall and Safety Communication

FDA's issues with Custom Ultrasonics' AERs date back to before 2007, when the agency entered into a consent decree with the company over "repeated violations of the Quality System Regulation." In 2012 and 2013, the agency ordered Custom Ultrasonics to stop producing its AERs after failing to obtain a clearance for a change to the devices' software.

FDA did not recommend healthcare providers stop using existing Custom Ultrasonics AERs until November 2015, when it issued a mandatory recall calling for alternative cleaning methods. In February, FDA rejected a request from Custom Ultrasonics to allow the company to correct the devices rather than recall them.

However, since then, FDA says it was unable to find an association between Custom Ultrasonics' devices and bacterial infections with other types of flexible endoscopes. As such, the agency says the devices should "remain available for use reprocessing flexible endoscopes that are not duodenoscopes."

For now, FDA says healthcare providers using duodenoscopes should rely on alternatives to Custom Ultrasonics' devices.

"There are four companies that currently manufacture AERs labeled to reprocess duodenoscopes in use in health care facilities: ASP, Medivators, Olympus America and Steris Corporation. The FDA has reviewed validation test methods and performance data for these AER manufacturers on the market that are indicated for reprocessing duodenoscopes and found that data from all to be adequate," FDA spokesperson Angela Stark told Focus.


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